YOMI ROBOTIC SYSTEM
Received Nov 13, 2023 · Event occurred Oct 13, 2023
Report 3012787974-2023-80079 · MDR key 18127880
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS PARTIALLY COMPROMISED THE BUCCAL WALL. A POST OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED. A SLIGHT HANDPIECE ROTATION WAS DETERMINED TO BE THE LIKELY ROOT CAUSE OF THE EVENT AS IT WOULD EXPLAIN THE 1.0 MM ERROR DURING THE LANDMARK CHECK AND ALSO WHY PART OF THE IMPLANT WAS OUTSIDE THE BUCCAL WALL. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT. THERE WERE NO FURTHER ISSUES NOTED WITH THE REPLACED IMPLANT AS WELL AS THE 2ND IMPLANT PLACEMENT. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.
Additional Manufacturer Narrative
CORRECTION: G3.